Prospective Clinical Trial of the LensAR Laser System

Lensar

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Cataract

Treatments

Device: Conventional phacoemulsification

Device: LensAR Laser System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01014702

52-00006-000

Details and patient eligibility

About

The LensAR Laser System is used to create an opening in the anterior capsule of the lens and fragments the cataractous lens. The study will evaluate clinical outcomes compared to the contra-lateral eye treated with conventional phacoemulsification surgery.

Enrollment

100 estimated patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects must sign and be given a copy of the written informed consent form
Subjects must have elected to undergo lens extraction and IOL implantation and then elect to have the LensAR laser surgery as part of the procedure.
Subjects must be willing and able to return for scheduled follow-up examinations for 6 months after surgery.
Subjects must have central 7 mm of clear cornea without vascularization.

Exclusion criteria

Subjects who have undergone previous corneal or intraocular surgery in the eye to be treated.
Subjects with a history, signs or symptoms of ocular disease or atypical finding which would be contraindicated under standard of care for cataract surgery.
Diabetic or hypertensive subjects with clinical evidence of retinal pathology.
Subjects with macular degenerative pathology.
Subjects with a history of steroid-responsive rise in IOP or uncontrolled glaucoma in either eye.
Subjects with known lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.
Subjects with corneal disease or pathology that precludes applanation of the cornea or transmission of laser wavelength or distortion of laser light.